(27 days)
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
- · eSie Volume Viewer
- eSie LVA
- · eSie PISA
- · eSie Valves
syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).
The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.
The syngo® Ultrasound Apps Suite™ (sUSAS) is a software-only product intended for image processing, manipulation, and quantification of ultrasound images from the ACUSON SC2000™ Ultrasound System on a PACS workstation. It supports several clinical application packages (CAPS): eSie Volume Viewer, eSie LVA, eSie PISA, and eSie Valves.
The device's acceptance criteria and proven performance are primarily established through a demonstration of substantial equivalence to a predicate device (eSie Apps Suite, K143254) and a secondary predicate (ACUSON SC2000 Diagnostic Ultrasound System v6.0, K200585), rather than through a standalone clinical study with specific performance metrics against an independent ground truth. The submission emphasizes that the subject device utilizes the same fundamental scientific technology and intended use/indications for use as the predicate device. Non-clinical testing for verification and validation was performed.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance results for human readers or algorithm-only performance. Instead, substantial equivalence is claimed based on functional and technological characteristics matching or improving upon the predicate devices. The "performance" is demonstrated through alignment with the predicate's capabilities and additional updated features.
| Feature / Characteristic | Predicate Device (eSie Apps Suite K143254) | Reported Device Performance (syngo® Ultrasound Apps Suite™ (sUSAS)) | Acceptance Criterion (Implicit) |
|---|---|---|---|
| Intended Use/Indications for Use | To launch Siemens CAPs for image processing, display, manipulation, quantification for clinical diagnosis. Supports eSie Volume Viewer, eSie LVA, eSie PISA, eSie Valves. | SAME AS PREDICATE | The indications for use must be substantially equivalent to the primary predicate device. |
| Clinical Application Packages (CAPS) | eSie Volume Viewer, eSie LVA, eSie PISA, eSie Valves. | SAME as predicate (K143254) and secondary predicate (K200585) | The device must include the same clinical application packages with equivalent functionality as the primary predicate and align with the version on the secondary predicate (SC2000 v6.0) for consistent performance. |
| Left Ventricle volume quantitative analyses (eSie LVA) | Supports Single + Multibeat (up to 3 beats implied from predicate date) | YES (eSie LVA) + 5 beats; SAME As SC2000 6.0 | Must perform 3D Left Ventricle volume quantitative analyses. Improvement from 3 to 5 cardiac cycles is an accepted update aligned with SC2000 6.0. |
| Quantification of proximal isovelocity surface area (eSie PISA) | 2D data acquired with TTE probe | YES (eSie PISA); 2D and 3D volume data acquired with TTE, and TEE probes. Color Doppler only. | Must perform quantification of proximal isovelocity surface area. Expanded support for 3D volume data and TEE probes from SC2000 6.0, and Color Doppler only, is acceptable. |
| Volume Load Performance (Volume review) | 80 secs | 40 secs; SAME AS VA16A | Volume loading time in volume review should be 80 seconds or less. An improvement to 40 seconds is acceptable. |
| Windows 10 Support | No | YES (New) for VA17A; SAME as SC2000 6.0 | The updated device must support current operating systems (Windows 10) in alignment with related devices (SC2000 6.0). |
| Display Improvements (e.g., VR Measurement Tools, Reference Lines) | No | YES; aligns with SC2000 6.0 | Display improvements like VR Measurement Tools, Reference Lines, One-click MPR alignment, Volume Reference Line Projections, Trace erase, and consolidated windows should align with SC2000 v6.0 capabilities, indicating enhanced user experience without altering fundamental technology or intended use. |
| Software Verification & Validation | N/A (Previous clearance) | Conforms to IEC 62304, IEC 62366-1, NEMA PS 3.1-3.20 (DICOM), ISO 14971. | The software must undergo verification and validation according to design control requirements and relevant international standards (IEC 62304, IEC 62366-1, NEMA PS 3.1-3.20 (DICOM), ISO 14971), and cybersecurity considerations must be addressed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical performance evaluation with human readers or an algorithm-only study. The submission relies on non-clinical verification and validation testing of the software to ensure it meets specifications and claims of functioning identically or with minor beneficial updates compared to the predicate device. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not provided as it would typically be for a clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no specific clinical test set and human performance comparison is detailed, information regarding the number of experts or their qualifications for establishing ground truth is not applicable or provided in this submission for determining substantial equivalence based on clinical outcomes. Ground truth for non-clinical software testing would be based on design specifications and expected behavior.
4. Adjudication Method for the Test Set
Since no clinical test set requiring expert adjudication for ground truth establishing is described, information on the adjudication method (e.g., 2+1, 3+1, none) is not applicable or provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission states, "clinical studies were not required to support substantial equivalence" because the device uses the "same technology and operating principles as the predicate device." Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone (algorithm only) performance study against a specific ground truth. The device is software that launches clinical application packages. Its effectiveness is tied to its functional equivalence to existing validated software on predicate devices. The "performance" is therefore inherent in the established and proven functionality of the CAPS, not a new standalone AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the claims of substantial equivalence and based on the non-clinical verification and validation, the ground truth is implicitly the established and validated functionality and performance of the predicate device (eSie Apps Suite) and the ACUSON SC2000 Diagnostic Ultrasound System v6.0. This refers to adherence to specifications, expected software behavior, and the established clinical utility of the underlying CAPS, rather than a clinical ground truth derived from pathology or outcomes data specifically for this submission.
8. The Sample Size for the Training Set
The document does not describe a training set for a machine learning or AI algorithm. The device is primarily an application suite with image processing and quantification tools, not a newly developed AI algorithm requiring a dedicated training set as described in clinical AI/ML regulatory submissions.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, information on how its ground truth was established is not applicable.
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May 18, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions, USA, Inc. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043
Re: K201062
Trade/Device Name: syngo Ultrasound Apps Suite™ (sUSAS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 17, 2020 Received: April 21, 2020
Dear Ms. Dunbar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
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regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201062
Device Name syngo® Ultrasound Apps. Suite™ (sUSAS)
Indications for Use (Describe)
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
- · eSie Volume Viewer
- eSie LVA
- · eSie PISA
- · eSie Valves
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1.1.3 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c)
| Date prepared: | May 04, 2020 |
|---|---|
| Part 1. Sponsor: | Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043 |
| Contact Person: | Christine DunbarSenior Regulatory AffairsSiemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043Email: Christine.dunbar@siemens.comTel: (925) 374-2045 |
| Part 2. Device Name: | syngo® Ultrasound Apps Suite™ (sUSAS) |
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | Picture Archiving and Communications System |
| Classification: | Regulatory Class: IIReview Category: Tier II |
| Classification Panel | Radiology |
| CFR Section | 21 CFR §892.2050 |
| Product Code | 90-LLZ |
| Legal Manufacturer: | Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043 |
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Part 3. Legally Marketed Predicate Devices
The syngo® Ultrasound Apps Suite™ (sUSAS) as described in this 510(k) submission is substantially equivalent to the company's legally marketed device, the eSie Apps Suite as represented below:
| Primary PredicateDevice | 510(k) Number / ClearanceDate / ProCode | Substantial Equivalenceclaimed to: |
|---|---|---|
| eSie Apps Suite (PrimaryPredicate) | K143254 / 12/10/2014 /LLZ | Syngo® Ultrasound AppsSuite VA17A image display,manipulation, post-processing with ClinicalApplications Packages(CAPS)• Volume Review• eSie LVA• eSie PISA• eSie Valves• Including imagesupport for SC2000v6.0 image data. |
| Secondary PredicateDevice Name | 510(k) Number / ClearanceDate | Substantial Equivalenceclaimed to: sUSASsupport clinical imagereview and postprocessing using thesame CAPS. |
| ACUSON SC2000Diagnostic UltrasoundSystem (v5.1) – VB21AReference Predicate | K200585 / 04/22/2020 / IYO | ACUSON SC2000Diagnostic Ultrasoundsystem image display,manipulation, post-processing with ClinicalApplications Packages(CAPS)• Volume Review• eSie LVA• eSie PISA• eSie Valves |
| Reference PredicateDevices | 510(k) Number / ClearanceDate | sUSAS supports clinicalimage review and postprocessing using thesame CAPS. |
| Syngo® Dynamics PACSystem, VA30A | K171053 / June 1, 2017 /LLZ | Syngo Dynamics PACSystem, VA30A and earlierPACS versions supports thesUSAS Plug-in andlaunches the clinicalapplications packages(CAPS) contained in thesUSAS application. |
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Part 4. Device Description
syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).
The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.
Part 5. Intended Use and Indications for Use Statement
The syngo® Ultrasound Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis. The software supports the following clinical application packages:
The software supports the following clinical application pack.
- . eSie Volume Viewer
- . eSie LVA
- . eSie PISA
- . eSie Valves
The indications for use for syngo® Ultrasound Apps Suite™ (sUSAS), VA17A remains unchanged from the primary predicate device eSie Apps Suite currently cleared in K143254 except for the device name.
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Part 6. Technological Characteristics as compared to Predicate Device
The subject device: syngo® Ultrasound Apps Suite ™ (sUSAS) is substantially equivalent to the cleared primary predicate device, eSie Apps Suite (K143254) that employs the same fundamental scientific technology and intended use/indications for use.
The clinical applications packages (CAPS) are the same version as used on the currently cleared SC2000 Diagnostic Ultrasound system v6.0 cleared under K200585 to ensure consistent functionality between the SC2000 Diagnostic Ultrasound system and the sUSAS software plug-in applications. Therefore, the SC2000 v6.0 K200585 is a secondary predicate as v6.0 contains the same CAPS as sUSAS VA17A and syngo® Dynamics PACs K171053 will be used as a reference predicate since the sUSAS application is installed as a plug-in and will be included in the comparison table.
A comparison table as Table 2 is provided on the following page:
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| Table 1: List of Technological Characteristics and SE Comparison Table | ||||
|---|---|---|---|---|
| Feature /Characteristic | eSie Apps Suite K143254(Predicate device) | ACUSON SC2000Ultrasound SystemK200585(Secondary Predicate)Syngo Dynamics K171053(Reference Predicate) | syngo® Ultrasound AppsSuite™ (SUSAS)(this submission) | |
| Device Classification(Device class/Productcode &panel/description) | Class IILLZ & RadiologyPicture archiving andCommunications system | Class IIIYN, IYO, ITX, OBJUltrasonic pulsed dopplerimaging system – and -Class IILLZ - PACS | Class IILLZ & RadiologyPicture archiving andCommunications system | |
| IntendedUse/Indication forUse statement | eSie Apps Suite software is asoftware-only product to berun on a user's PACS (PictureArchiving andCommunication System)workstation. It is intendedto launch Siemens CAPs(Clinical ApplicationPackages) for imageprocessing, including theacceptance, transfer, displayand digital processing ofultrasound images. Digitalprocessing includes imagemanipulation andquantification on aworkstation. Use of a clinicalapplication package by aqualified clinician can addinformation to the study to beused for a clinical diagnosis.The software supports thefollowing clinical applicationpackages:• eSie VolumeViewer• eSie LVA• eSie PISA• eSie Valves | See clearance letter forK200585 in AttachmentB2a.See reference deviceclearance letter forK171053 in AttachmentB3. | syngo® Ultrasound AppsSuite software is a software-only product to be run on auser's PACS (PictureArchiving and CommunicationSystem) workstation. It isintended to launch SiemensCAPs (Clinical ApplicationPackages) for imageprocessing, including theacceptance, transfer, displayand digital processing ofultrasound images. Digitalprocessing includes imagemanipulation andquantification on aworkstation. Use of a clinicalapplication package by aqualified clinician can addinformation to the study to beused for a clinical diagnosis.The software supports thefollowing clinical applicationpackages:• eSie VolumeViewer• eSie LVA• eSie PISA• eSie ValvesSAME AS PREDICATE | |
| YES -(eSie volume viewer) | Yes - SC2000 6.0 and lower | SAME - (eSie volume viewer) | ||
| ■ | Viewing andmanipulation ofvolume datasets | YES -(eSie volume viewer) | ||
| Yes - syngo Dynamics viasUSAS installed | ||||
| ■ | 2D quantitativetool forassessment ofglobal andregionalmyocardialmechanics | No | Yes SC2000 only(eSie VVI) | No |
| No - syngo Dynamics viasUSAS installed | ||||
| ■ | 3D LeftVentricle volumequantitativeanalyses (Single+ Multibeat) | YES (eSie LVA) | Yes - SC2000(eSie LVA) +5 beats | YES (eSie LVA) + 5 beatsUpdate to number ofcardiac cycles supportedfrom 3 to 5 beats, SAMEAs SC2000 6.0 |
| No - syngo Dynamics viasUSAS installed | ||||
| ■ | Quantification ofproximalisovelocitysurface area | YES (eSie PISA)2D data acquired with TTEprobe | Yes - SC2000(eSie PISA) 2D and 3Dvolume date acquired withTTE, TEE and ICE probes.Color Doppler & B mode. | YES (eSie PISA)2D and 3D volume dateacquired with TTE, and TEEprobes.Color Doppler only. |
| No- syngo Dynamics viasUSAS installed | ||||
| ■ | 2D Automatedtool to identifyand measurecontours of leftventricle andatrium fromtransthoracicexams (TTE) | No | Yes - SC2000(eSie Left Heart) | No |
| No- syngo Dynamics viasUSAS installed | ||||
| ■ | Visualize andquantify mitraland aortic valveanatomy | YES (eSie Valves) | Yes - SC2000(eSie Valves) | YES (eSie Valves)Same as SC2000 6.0 withdefect corrections |
| No - syngo Dynamics viasUSAS installed | ||||
| ■ | GUDIDCompliance | Yes VA16A | Yes - SC2000 | YESVA16A |
| Yes - syngo Dynamics | ||||
| ■ | Volume LoadPerformance | 80 secs | N/A for SC2000 | 40 secsSAME AS VA16A |
| (Volume loadtime in volumereview) | ||||
| ■ Support SC2000datasetscompatibility | Yes -VA16A - v5.0VA16B - v5.1 | Yes - syngo DynamicsVA30A and earlier via sUSASinstalled. | Yes, SC20006.0 clearance (K200585) | |
| ■ eSie PISA andTTE (onlysupport withTTE ColorDoppler volumedata) | YES VA16A | Yes for SC2000 5.0 andhigher.----------------------------------Yes, supported on syngoDynamics imaging via sUSASVA16A | YES (eSie PISA)Supports TTE Color DopplerVolume same as VA16A | |
| ■ Syngo Dynamics(sUSAS supportfor SC2000 5.1data) | YES SyDx VA10 | Yes - syngo DynamicsWith sUSAS VA16B | YES SyDx VA20 | |
| ■ Syngo Dynamics(sUSAS supportfor SC2000 6.0data) | YES SyDx VA10 | Yes - syngo DynamicsWith sUSAS VA17A | YES SyDx VA20 | |
| ■ Windows 10Support | No | Yes - SC2000 6.0----------------------------------Yes - syngo Dynamics viasUSAS installed | YES (New) for VA17ASAME as SC2000 6.0 | |
| ■ DICOM MediaStorage Service | YES | Yes - SC2000 6.0 and lower----------------------------------Yes - syngo Dynamics viasUSAS installed | YES - SAME | |
| ■ DICOM StructedReporting | YES | Yes - SC2000 6.0 and lower----------------------------------Yes - syngo Dynamics viasUSAS installed | √ YES - SAME | |
| ■ DisplayImprovements | No | SC2000 v6.0 - Yes | Yes aligns with SC20006.0 | |
| VR MeasurementTools■ (Volume) | No | SC2000 v6.0 - Yes | The ability to measure anatomyand pathology directly on theVolume Rendered (VR) imagesin CINE and acquired in 4D.Same as on SC2000 6.0 | |
| Reference LinesOne-click MPRalignment■ | No | SC2000 v6.0 - Yes | New Display FeatureSame as on SC2000 6.0 | |
| Volume ReferenceLine ProjectionseSie Slice / eSieLines■ | No | SC2000 v6.0 - Yes | New Display FeatureSame as on SC2000 6.0 | |
| ■ One-click MPRA/B Align onVolume Review(VR) | No | SC2000 v6.0 - Yes | New Display FeatureSame as on SC2000 6.0 | |
| ■ Trace erase, backup behavior withTrackball: B-Mode | No | SC2000 v6.0 - Yes | Updated DisplayFeature Same as onSC2000 6.0 | |
| ■ D'Art renamedSingle V | No | SC2000 v6.0 - Yes | YES - Consolidatedwindows Same as onSC2000 6.0 |
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Substantial Equivalence Conclusion:
From the information provided in Table 2 above; it is understood that the subject device does not introduce any new fundamental technology or modify the indications of use; therefore, sUSAS VA17A is considered substantially equivalent to the predicate device: the eSie Apps Suite VA15A cleared in K143254 utilizing the same Clinical Applications (CAPS) as cleared on the Secondary predicate ACUSON SC2000 Diagnostic Ultrasound System v6.0 (K20085) The sUSAS VA17A is intended to be a plug-in on a PACS such as the the reference predicate syngo® Dynamics PACS workstation (K171053) or earlier versions.
Part 7. A brief discussion of nonclinical testing submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
svngo® Ultrasound Apps Suite™ (sUSAS) is verified, and validated according to the design control requirements of 21 CFR 820.30 and has been subjected to extensive safety and requirements verification testing before release to ensure the device meets all its specifications including conformance to the following standards:
- IEC 62304:2006/A1:2016 Medical Device Software Software Life Cycle Processes ●
- IEC 62366-1:2015, Application of usability engineering to medical devices. ●
- NEMA PS 3.1 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM set). ●
The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.
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Software Verification and Validation
In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.
Cybersecurity considerations related to the sUSAS software only plug-in is included within this submission. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
A risk analysis, in compliance with ISO 14971:2007, for sUSAS was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirm that all software specifications have been implemented and met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.
Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
syngo® Ultrasound Apps Suite™ (sUSAS) is a class II device and uses the same technology and operating principles as the predicate device; eSie Apps Suite (K143254), therefore clinical studies were not required to support substantial equivalence.
Part 9. Safety and Effectiveness Information
Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards. The device does not come into contact with the patient and is only used by trained
professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.
Siemens believes that syngo® Ultrasound Apps Suite, version VA17A is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.
Part 10. Conclusion as to Substantial Equivalence Summary
Based on the information provided here in the summary and from the device comparison in Table 2; the syngo® Ultrasound Apps Suite™ (sUSAS); VA17A has the same indications for use as the primary predicate device (K143254) (except new product name); incorporates technological features
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of the primary predicate device and the same Clinical Applications Packages (CAPS) as the primary predicate (K143254) and as the secondary predicate device (K200585) cleared through premarket notification and performance testing which indicates that no new issues of safety or effectiveness are raised.
Siemens Medical Solutions USA, Inc, Ultrasound Business Unit. considers the syngo® Ultrasound Apps Suite™ (sUSAS) VA17A to be substantially equivalent with respect to safety and effectiveness to the previously cleared predicate device for the U.S. market.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).